Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Trial Parameters
Brief Summary
The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib. Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.
Eligibility Criteria
Inclusion Criteria: Informed consent 1. Ability to understand the purpose and risks of the study and capable of giving signed informed consent which includes: 1. Compliance with the requirements and restrictions listed in the informed consent form (ICF). 2. Authorization to use protected health information/data \[in accordance with the General Data Protection Regulation (GDPR)\]. 2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses 3. Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty. Age/Sex 4. Men and women \>80 years of age or \>60 up to 80 years of age and ineligible for full dose R-CHOP according to investigator assessment\*. We recommend classifying patients aged 61-80 as full-dose R-CHOP ineligible if they fulfill one of the following criteria: ADL \<5, IADL \<6, CIRS-G ≥1 score = 3, or \> 8 score = 2. 5.